QA Auditor I – GLP Compliance & Audits

Inotiv; North Carolina; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health and dental coverage

Short- and long-term disability

Paid time off

Paid parental leave

401K

Job summary

Inotiv is seeking a QA Auditor to ensure GLP compliance across studies and facilities. You will perform audits, review protocols, and prepare QA reports while maintaining regulatory alignment with FDA/EPA standards.

The role requires a bachelor’s degree in chemistry or life sciences and 2–4 years of regulated experience, with strong written and verbal communication and the ability to work independently.

Qualifications

• Bachelor's degree in chemistry or life sciences or related field.
• 2–4 years of experience in a GLP or similarly regulated environment with auditing experience preferred.
• Equivalent combination of education and regulatory, quality, compliance and/or industry experience.

Responsibilities

• Demonstrate solid understanding of FDA and EPA GLPs and applicable international regulations.
• Keep current with new rules, guidance, and industry standards to improve laboratory compliance.
• Conduct audits of designated studies and facilities to assess compliance with protocols and SOPs.
• Review study data and reports and facility records for regulatory alignment.
• Prepare audit reports and submit findings to Study Director/Principal Investigator promptly.
• Issue accurate QA statements for inclusion in final reports.
• Familiarize with electronic data systems, including Part 11 compliance and QC.
• Input/update information in Master Schedule per GLP regulations and SOPs.
• Independently conduct process or facility inspections and assist with sponsor/regulator audits.
• Provide quality training for new hires and other staff as assigned.
• Participate in subcontractor/vendor evaluations and regulatory projects.
• Serve as a QA resource on regulatory topics during meetings.

Skills

GLP Auditing

Regulatory knowledge

QA Documentation

Audit reporting

SOP compliance

Regulatory training

Analytical thinking

Data integrity

Communication skills

Education

B.S. in Chemistry/Life Sciences

Bachelor's or higher in related field

Equivalent education/experience

Job description

Inotiv is seeking a QA Auditor to ensure GLP compliance across studies and facilities. You will perform audits, review protocols, and prepare QA reports while maintaining regulatory alignment with FDA/EPA standards.

The role requires a bachelor’s degree in chemistry or life sciences and 2–4 years of regulated experience, with strong written and verbal communication and the ability to work independently.